GALDERMA LABORATORIES, L.P. Vectical Ointment is a translucent ointment containing 3 mcg/g (0.0003% w/w) of calcitriol, packaged in aluminum tubes with screw caps. calcitriol topical, methyclothiazide. Minor/Significance Unknown. Apply Vectical Ointment to the affected areas 2 times each day in the morning and evening. Minor/Significance Unknown. Before using this medication, tell your doctor or pharmacist your medical history, especially of: high calcium/vitamin D levels (hypercalcemia/hypervitaminosis D), kidney disease, liver disease. To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 866-735-4137 or FDA at 1-800-FDA-1088 or. The chemical name of the active ingredient is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol. Potential additive hypercalcemia. (2) Avoid or Use Alternate Drug. Please confirm that you would like to log out of Medscape. VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. Pediatric Patients The systemic exposure of calcitriol was assessed in pediatric subjects ages 2 to 17 years with plaque psoriasis in two trials. Marketed by: GALDERMA LABORATORIES, L.P.Dallas, Texas 75201 USA Tell your doctor about all other medicines you are using to treat psoriasis. Do not take other supplements/vitamins (such as calcium, vitamin D) unless ordered by your doctor.Certain medications (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the absorption of vitamin D. Separate your doses of these medications as far as possible from your doses of calcitriol (at least 2 hours apart, longer if possible). Gently rub in. Not for ophthalmic, oral or intravaginal use. The ointment should not be applied to the face or the vaginal area. NDC 0299-2012-10 In controlled clinical trials hypercalcemia was observed in subjects exposed to Vectical Ointment. are breastfeeding or plan to breastfeed. In controlled clinical trials hypercalcemia was observed in subjects exposed to VECTICAL Ointment. This medicine is a clear, translucent, ointment, Select a condition to view a list of medication options. Minor/Significance Unknown. Vectical Ointment is a prescription medicine used on the skin (topical) to treat mild to moderate plaque psoriasis in adults and children 2 years and older. This medication may rarely increase calcium in your blood. Share cases and questions with Physicians on Medscape consult. (1.1) Minor/Significance Unknown. Clinical Considerations Gently rub in. Topically applied calcitriol can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)]. What are the new treatments for plaque psoriasis? If aberrations in parameters of calcium metabolism are noted discontinue VECTICAL Ointment until these normalize. Do not double the dose to catch up. Rx Only Save 2.20. This document does not contain all possible drug interactions. Each gram contains: calcitriol 3mcg in an ointment base consisting of mineral oil, dl--tocopherol, and white petrolatum, Storage: Store at controlled room temperature 68 - 77 (20 -25C) with excursions permitted between 59 - 86F (15 - 30C). Minor/Significance Unknown. Vectical Ointment is for topical use only. Pediatrics: 2 to 6 years of age: the maximum weekly dose should not exceed 100 grams. Minor/Significance Unknown. Specific Populations Apply a thin layer of the medication and rub it in completely. Do not share this medicine with another person, even if they have the same symptoms you have. Serious - Use Alternative (1)calcitriol topical, aminolevulinic acid topical. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Tell your healthcare provider about all of the medicines you take. You may report side effects to FDA at 1-800-FDA-1088. Minor (1)calcitriol topical, cyclopenthiazide. This medication has been prescribed for your current condition only. US Patent No. Stop using this medicine and call your doctor at once if you have: blistering, or severe redness, itching, or other irritation of treated areas; or. Listing a study does not mean it has been evaluated by the U.S. Federal Government. $500. Medscape Education, The Dermatology Medscape Clinic: Managing Psoriasis in Sensitive Areas, 20021107949-overviewDiseases & Conditions, encoded search term (calcitriol topical (Vectical)) and calcitriol topical (Vectical), FDA Approves Calcitriol Ointment for Psoriasis, Current Effective Topical Therapies in the Management of Psoriasis. Potential additive hypercalcemia. Apply only enough VECTICAL Ointment to cover your affected skin area. With insurance. Studies in which male and female rats received oral doses of calcitriol of up to 0.6 mcg/kg/day (3.6 mcg/m2/day) indicated no impairment of fertility or general reproductive performance. It works by promoting blood flow. Topical calcitriol may lead to hypercalcemia. Access your plan list on any device mobile or desktop. Consult your pharmacist or local waste disposal company. Your doctor may check your calcium and phosphate blood levels and adjust your dose if you have side effects.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Keep all medical and lab appointments. Either increases toxicity of the other by pharmacodynamic synergism. Avoid contact with eyes, lips, and facial skin. Mechanism of action for psoriasis has not established, Do not apply to the eyes, lips, or facial skin, Not for oral, ophthalmic, or intravaginal use, Store at room temperature 68-77F (20-25C); excursions permitted to 59-86F (15-30C). The molecular formula is C27H44O3, and the molecular weight is 416.64. Development timeline for Vectical Further information Risk Summary VECTICAL Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. US residents can call their local poison control center at 1-800-222-1222. It is not known if VECTICAL Ointment will harm your unborn baby. For topical use only. (2), For topical use only. Do not freeze or refrigerate VECTICAL Ointment. Generic name: calcitriol Dosage form: Ointment Company: Galderma Laboratories, L.P. Consult your doctor before breast-feeding. RxNorm, There are no data on the presence of calcitriol in human milk, the effects on the breastfed infant or on milk production after treatment with VECTICAL Ointment. Otherwise, call a poison control center right away. Potential additive hypercalcemia. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis. SIDE EFFECTS: Calcitriol does not usually have side effects. Generic name: calcitriol In two, multicenter, double-blind, vehicle-controlled studies, a total of 839 subjects with psoriasis rated "mild" or "moderate" using an investigator global assessment scale were treated twice daily for 8 weeks. Gently rub Vectical Ointment into the affected area until it disappears into your skin. (, VECTICAL Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics, and in patients receiving calcium supplements or high doses of vitamin D. (, a vehicle controlled 8-week trial in 19 subjects 2 to 12 years of age with mild to moderate plaque psoriasis, an open-label 8-week safety and pharmacokinetics (PK) trial in 25 subjects 12 to 17 years of age, an open-label 14-day safety and PK trial in 18 subjects 2 to 12 years of age; and. Follow your doctor's directions carefully. Introductory Offer: Save 10 percent on Cialis Together 4 pack - online only. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Drug class: Topical antipsoriatics. Minor (1)calcitriol topical increases levels of calcium acetate by pharmacodynamic synergism. Minor/Significance Unknown. General information about the safe and effective use of VECTICAL Ointment. Medically reviewed by Drugs.com. The population included subjects ages 13 to 87, males (284) and females (135), Caucasians (372) and non-Caucasians (47); with mild (105) to moderate (313) chronic plaque psoriasis. Learn about a popular treatment for psoriasis. NDC 0299-2012-10 Ask your doctor or pharmacist about finding a good dosing schedule that will work with all your medications. Minor/Significance Unknown. Indications and Usage (1) Date 07/2020 Dosage and Administration (2) Date 07/2020, VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. 5705185. Inactive ingredients: mineral oil, dl--tocopherol, and white petrolatum. [See USP Controlled Room Temperature.] provider for the most current information. Vectical Ointment under maximum use conditions in 25 evaluable pediatric subjects with psoriasis aged 12 to 17. Minor (1)calcitriol topical, chlorothiazide. Files, All Mapping Children 2 to 6 years of age should not use more than 100 grams in 1 week. Minor/Significance Unknown. Full Drug Information. Call your doctor if you have any of these symptoms. Minor/Significance Unknown. To help you remember, use it at the same times each day. Use this medication on the skin only. calcitriol topical increases levels of calcium gluconate by pharmacodynamic synergism. ( 2) The maximum weekly dose should not exceed 200 g. an open-label 26-week safety and PK trial in 54 subjects 2 to 17 years of age. Not all possible drug interactions are listed here. VECTICAL Ointment should be used with caution in patients receiving medications known to increase the serum calcium level, such as thiazide diuretics, and in patients receiving calcium supplements or high doses of vitamin D. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. It is not known if VECTICAL Ointment is safe and effective in people with known or suspected problems with calcium metabolism. No effects on reproductive or fetal parameters were observed in rats. It is not known if Vectical Ointment is safe and effective in children under 2 years of age. (2) Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Vectical Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. are breastfeeding or plan to breastfeed. This medication is to be used as directed by the physician. Authors: News Author: Laurie Barclay, MD CME Author: Yael Waknine Log In to Start THIS ACTIVITY HAS EXPIRED FOR CREDIT Target Audience and Goal Statement Four hundred and nineteen subjects were treated with Vectical Ointment twice daily for 8 weeks. Available data from pregnancies that occurred during the clinical development of Vectical Ointment and published case series of oral and intravenous calcitriol use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. If any of these effects last or get worse, notify your doctor or pharmacist promptly. Do not store in the bathroom. This medication is used to treat psoriasis. Vectical slows my psoriasis flareups enough to make this a great routine for me. Clobex works great for me but I can't use it regularly. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. A two-year carcinogenicity study was conducted in which calcitriol was orally administered to rats at dosages of approximately 0.005, 0.03, and 0.1 mcg/kg/day (0.03, 0.18, and 0.6 mcg/m2/day, respectively). Potential additive hypercalcemia. P51460-6, PATIENT INFORMATIONVECTICAL (Vek te kal) (calcitriol) Ointment. Either increases toxicity of the other by pharmacodynamic synergism. Discuss with your doctor the maximum amount of medication you may use per day (or per week). Animal Data Embryo-fetal development studies with calcitriol were performed in which rats were treated orally at dosages up to 0.9 mcg/kg/day (5.4 mcg/m2/day) and in which rabbits received topical application of calcitriol ointment (3 ppm) to 6.4% of the body surface area. The mean age of the subjects was 48 years and 66% were male; most subjects were rated "moderate" at baseline. All Drug Estimated insurance price. calcitriol topical, chlorothiazide. This product is available in the following dosage forms: Ointment restrictions. You should not cover the treated area(s) with a waterproof (occlusive) bandage or overdosage may occur. Too much calcium in your blood (hypercalcemia) may occur with VECTICAL Ointment. Events, (What Most You should usually begin to see an improvement in your skin condition after 4 weeks of treatment. P51460-6, PATIENT INFORMATION Either increases toxicity of the other by pharmacodynamic synergism. Consult your pharmacist or local waste disposal company. Topical calcitriol may lead to hypercalcemia. The maximum weekly dose should not exceed 200 grams. Active ingredient: calcitriol The safety and effectiveness of VECTICAL Ointment in pediatric subjects below the age of 2 years have not been established. It is not known whether topical administration of calcitriol could result in sufficient systemic absorption to produce detectable quantities in human milk. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Minor (1)calcitriol topical increases levels of calcium carbonate by pharmacodynamic synergism. Minor/Significance Unknown. 4 UNI | 4.95 per 1UNI. ), More about getting RSS News & Updates from DailyMed, 100 g in 1 TUBE; Type 0: Not a Combination Product, 5 g in 1 TUBE; Type 0: Not a Combination Product, 15 Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Subjects were randomized in a 1:1 ratio to receive either VECTICAL Ointment or vehicle ointment. Drug Description Find Lowest Prices on DESCRIPTION VECTICAL ( calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. If you use VECTICAL Ointment and breastfeed, do not apply VECTICAL Ointment to your nipple and areola to avoid getting VECTICAL Ointment into your babys mouth. Risk Summary Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . Made in Canada. Each drug may increase the photosensitizing effect of the other. Clinical Considerations Topical calcitriol may lead to hypercalcemia. P51459-6, methotrexate, Humira, Remicade, cyclosporine, Stelara, adalimumab. Write a review. Use Vectical Ointment on the skin only. If you use Vectical Ointment and breastfeed, do not apply Vectical Ointment to your nipple and areola to avoid getting Vectical Ointment into your babys mouth. Do not take supplements unless directed by your doctor. Potential additive hypercalcemia. Avoid getting it on healthy skin areas. Discuss the risks and benefits with your doctor. . Minor/Significance Unknown. commonly, these are generic drugs. What are the possible side effects of VECTICAL Ointment? View NDC Code(s)NEW! Table 1 describes adverse events in subjects treated with VECTICAL Ointment twice daily for 8 weeks. Do not use Vectical Ointment in your mouth, eyes, or vagina. calcitriol topical increases levels of calcium gluconate by pharmacodynamic synergism. These effects may have been secondary to maternal toxicity. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. What are the ingredients in VECTICAL Ointment? Take your next dose at the regular time. The population included subjects ages 13 to 87 years, males (284) and females (135), Caucasians (372 . In the US - Call your doctor for medical advice about side effects. a diuretic or "water pill" (such as hydrochlorothiazide, HCTZ, Diovan HCT, Hyzaar, Maxzide, Tenoretic, Zestoretic, and others). For topical use only. Minor/Significance Unknown. Vectical Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. Vectical Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in patients 18 years and older. (calcitriol) Ointment 3 mcg/g The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Without insurance. Vitamin D helps control parathyroid hormone and the levels of certain minerals (such as calcium, phosphorus) that are needed for building and keeping strong bones.Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. (2) 7 years of age and older: the maximum weekly dose should not exceed 200 grams. calcitriol topical increases levels of calcium acetate by pharmacodynamic synergism. It is practically insoluble in water, soluble in alcohol and in fatty oils. Generic name: CALCITRIOL 3ug in 1g Dosage form: ointment Drug class: Topical antipsoriatics Medically reviewed by Drugs.com. NET WT. Not for ophthalmic, oral or intravaginal use.Usual dosage: Apply to affected areas twice daily. Get Label RSS Feed, Do not give Vectical Ointment to other people, even if they have the same symptoms that you have. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Do not use VECTICAL Ointment in your mouth, eyes, or vagina. Either increases toxicity of the other by pharmacodynamic synergism. Vectical should not be given to a child younger than 2 years old. Either increases toxicity of the other by pharmacodynamic synergism. Does Vectical Ointment interact with other drugs you are taking? The contribution to efficacy of individual components of the vehicle has not been established. October 31, 2022. Before using Vectical Ointment, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VECTICAL (calcitriol) ointment 3 mcg/g, a vitamin D analog, was approved in 2009 for the topical treatment of mild to moderate plaque psoriasis in patients 18 years of age and older. Clinical Trials, To view formulary information first create a list of plans. This list is not complete. Information last revised December 2022. These effects may have been secondary to maternal toxicity. Not for ophthalmic, oral or intravaginal use. Four hundred and nineteen subjects were treated with VECTICAL Ointment twice daily for 8 weeks. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period. This information does not assure that this product is safe, effective, or appropriate for you. Use your next dose at the regular time. While both Clobex Spray and Vectical Ointment are indicated for the treatment of plaque psoriasis, this study was conducted to confirm the safety and efficacy of these products when used in a sequential regimen. View the formulary and any restrictions for each plan. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. You may report side effects to FDA at 1-800-FDA-1088. Kidney stones were reported in 3 subjects and confirmed in two. Risk Summary Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period. In Canada - Call your doctor for medical advice about side effects. In animal reproduction studies, topical administration of calcitriol to pregnant rabbits during the period of organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities (see Data). Topical administration of calcitriol to pregnant rabbits during organogenesis resulted in an increased incidence of fetal deaths, as well as an increased incidence of minor skeletal abnormalities, Available data do not allow the calculation of relevant comparisons between the systemic exposures of calcitriol observed in animal studies to the systemic exposures that would be expected in humans after topical use. VECTICAL (calcitriol) Ointment 3 mcg/g is a vitamin D analog intended for topical application to the skin. Talk to your healthcare provider about the best way to feed your baby during treatment with Vectical Ointment. US residents can call their local poison control center at 1-800-222-1222. Minor (1)calcitriol topical increases levels of calcium citrate by pharmacodynamic synergism. VECTICAL Ointment should not be applied to the eyes, lips, or facial skin. Each gram of Vectical Ointment contains 3 micrograms (mcg/g) of calcitriol. Do not apply to more than one-third of your body. Calcitriol topical ointment is used to treat mild to moderate plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. Tell your doctor right away if you have symptoms of high levels of calcium in your blood (hypercalcemia), including: nausea, vomiting, loss of appetite, constipation; Common Vectical side effects may include: This is not a complete list of side effects and others may occur. VECTICAL Ointment is a prescription medicine used on the skin (topical) to treat mild to moderate plaque psoriasis in adults and children 2 years and older. Tell your doctor about all your other medicines, especially: vitamin or mineral supplements that contain calcium or vitamin D; or. The incidence of benign pheochromocytomas was significantly increased in female rats. calcitriol topical, hydrochlorothiazide. Many people using this medication do not have serious side effects. Minor/Significance Unknown. Calcitriol did not elicit genotoxic effects in the mouse lymphoma TK locus assay. No new safety signals were identified in subjects 2 to 17 years [see Clinical Studies (14), Clinical Pharmacology (12.3) and Adverse Reactions (6.1)]. Especially tell your healthcare provider if you take: Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. The most frequent adverse events reported in clinical trials (>3%) were lab test abnormality, urine abnormality, psoriasis, hypercalciuria and puritus. GALDERMA. Either increases toxicity of the other by pharmacodynamic synergism. Store at room temperature. calcitriol topical increases levels of calcium citrate by pharmacodynamic synergism. worsened symptoms or no improvement in psoriasis. Vectical. VECTICAL Ointment 3 mcg/g is available in collapsible aluminum tubes of the following package sizes: Store at Controlled Room temperature 68 - 77F (20 - 25C) with excursions permitted between 59 - 86F (15 - 30C). 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